M. Sc. (Organic / Industrial Chemistry) or B. Sc. (Tech) or B.E. Chemical
10+ years experience of API Plant
Technical skills Competencies / Language
Leadership
Planning, organizing and decision making
Manpower Planning
Interpersonal skills and Communication
Ability for continuous improvement
Sound technical knowledge of plants and processes Influencing and decision-making
Participate, prepare, implement production schedule with desired quality and standard cost, ensuring safety and GMP requirements, effectively leading a team of subordinates and ensuring the upkeep and optimum utilities of plant and machinery in API.
KEY ACCOUNTABILITIES
Production
Preparing, reviewing, approving and distributing the instructions for the production of intermediates or APIs according to written procedures;
Producing APIs and, when appropriate, intermediates according to pre-approved instructions;
Reviewing all production batch records and ensuring that these are completed and signed;
Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded;
Making sure that production facilities are clean and when appropriate disinfected;
Making sure that the necessary calibrations are performed
Making sure that the premises and equipment are maintained and records kept
Making sure that validation protocols and reports are reviewed
Evaluating proposed changes in product, process or equipment
Making sure that new and, when appropriate, modified facilities and equipment are qualified.
Quality
Participate, implement and adhere to corporate guidelines , directives and local FDA requirement.
Ensure deviation and change control procedures are assessed within the desired timeframe.
Preparing for Internal and External audits.
HSE
Participate, implement, and adhere to Group HSE guidelines and regulatory requirements.
Lead, guide and maintain departmental EMS and EHS system.
Lead process-risk analysis for manufacturing operations
Organizing and maintaining the health , safety and environmental management system
Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations.
Cost Control
Prepare standard costs and budget, monitor and control revenue budget, material utilization, energy consumption and optimum material, machine and labour utilization.
Participating and Preparing of capital budget for technical up gradation, productivity improvement.
Trouble shooting
To identify, analyse and resolve issues related with process, equipment and manpower on day-to-day basis.
And initiate continues improvement in technical process in co ordination with process development.
People management
Provide training and develop subordinates to run the plant effectively in all the three shifts.
